| Zoster (shingles) |
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| Disease Issues |
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| Note:
In July 2020, Merck discontinued the sale of
Zostavax (live zoster vaccine) in the United
States. The latest expiration date of
remaining doses is November 2020. |
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What is the cause of herpes zoster (shingles)? |
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| Herpes zoster is
a painful rash that occurs along one or more
dermatomes. Zoster is caused by reactivation
of latent varicella zoster virus infection
from a prior chickenpox infection. People who
have had a prior infection with varicella
zoster virus (chickenpox) are at risk of
shingles. |
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| How common is
herpes zoster (shingles)? |
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| During their
lifetime about 30% of Americans will develop
herpes zoster, which translates into an
estimated 1 million cases each year in this
country. The risk of zoster increases with
increasing age; about half of all cases occur
among people age 60 years or older. People who
are immunosuppressed, including those with
leukemia, lymphoma, and human immunodeficiency
virus (HIV) infection, and people who receive
immunosuppressive drugs, such as steroids and
cancer chemotherapy, also are at greater risk
of zoster. Most people have only one episode
of shingles. The risk of recurrence is low in
people who are not immunosuppressed, but the
precise incidence is unknown. |
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| Can you catch
zoster from a person with active zoster
infection? |
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| Zoster is caused
by reactivation of a latent varicella virus
infection (from having chickenpox in the
past). Zoster is not passed from one person to
another through exposure to another person
with zoster. However, if a person who is
susceptible to chickenpox (i.e., they had
never had chickenpox and were not vaccinated
against chickenpox) comes in direct contact
with a person with a zoster rash, the virus
could be transmitted to the susceptible
person. The exposed person would develop
chickenpox, not zoster. Covering the zoster
rash reduces the chances of transmitting
varicella zoster virus. |
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| For our
"Mother's Day Out" program, one of the
teachers has shingles. The program serves moms
of 2-month-olds to 4-year-olds. All children
are up to date with their vaccinations, but
some are too young to have received varicella
vaccine. Is it safe for the teacher to work? |
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| In a school
setting, an immunocompetent person with zoster
(staff or students) can remain at school as
long as the lesions can be completely covered.
People with zoster should be careful about
personal hygiene, wash their hands after
touching their lesions, and avoid close
contact with others. If the lesions cannot be
completely covered and close contact avoided,
the person should be excluded from the school
setting until the zoster lesions have crusted
over. See
www.cdc.gov/chickenpox/outbreaks/manual.html
for more information. If your program is
licensed by a state or county, you should
check their regulations as well. |
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| Should
healthcare personnel in long-term care
facilities be tested to see if they have had
chickenpox before taking care of someone who
has shingles? |
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| All healthcare
personnel should ensure they are immune to
varicella regardless of the setting in which
they work. For healthcare personnel, accepted
evidence of varicella immunity includes any of
the following: 1) documentation of
age-appropriate vaccination with a varicella
vaccine, 2) laboratory evidence of immunity or
laboratory confirmation of disease; 3)
diagnosis or verification of a history of
varicella disease by a health-care provider;
or 4) diagnosis or verification of a history
of herpes zoster by a health-care provider. |
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| What zoster
vaccines are available in the United States? |
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| Recombinant
zoster vaccine (RZV, Shingrix,
GlaxoSmithKline) was licensed by the Food and
Drug Administration (FDA) in October 2017. It
is a subunit vaccine that contains recombinant
varicella zoster virus (VZV) glycoprotein E in
combination with a novel adjuvant (AS01B).
Shingrix does not contain live VZV. It is
FDA-approved and recommended by the Advisory
Committee on Immunization Practices (ACIP) for
people 50 years and older. Shingrix is
administered as a 2-dose series by the
intramuscular route. The second dose should be
given 2 to 6 months after the first dose. |
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| Zoster vaccine
live (ZVL, Zostavax, Merck) is a live
attenuated vaccine that was licensed by the
FDA in 2006 for adults age 50 and older and
recommended by ACIP for people age 60 and
older. It is administered as a single dose by
the subcutaneous route. In July 2020 Merck
discontinued the sale of Zostavax in the
United States; the latest expiration date of
remaining doses is November 2020. |
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| How effective
are zoster vaccines? |
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| Shingrix was
studied in 2 pre-licensure clinical trials.
Efficacy against shingles was 97% for persons
50–59 years of age, 97% for persons 60–69
years of age, and 91% for persons 70 years and
older. Among people 70 years and older vaccine
efficacy was 85% four years after vaccination. |
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| In clinical
trials Zostavax recipients age 50 and older
had a 51% overall reduction in shingles and
less severe illness when shingles did occur
compared with placebo recipients. Its efficacy
was lower in older age groups. Protection
against shingles declined over time after
vaccination. By 6 years after vaccination
protection declined to less than 35% overall. |
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| Will
administering zoster vaccine prevent
postherpetic neuralgia (PHN)? |
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| Yes. In clinical
trials, Shingrix reduced the risk of PHN by
91%. |
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| To whom should
zoster vaccine be given? |
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| ACIP published
its most recent zoster vaccination
recommendations in January 2018, available at
www.cdc.gov/mmwr/volumes/67/wr/pdfs/mm6703a5-H.pdf.
Its key recommendations are listed below. |
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- Shingrix is
recommended for the prevention of herpes
zoster and related complications for
immunocompetent adults 50 years of age and
older.
- Shingrix is recommended for the
prevention of herpes zoster and related
complications for immunocompetent adults who
previously received Zostavax.
- Zostavax remains a recommended vaccine
for prevention of herpes zoster and its
complications in immunocompetent adults 60
years of age and older. However, Shingrix is
preferred. [Note: Zostavax was withdrawn
from the U.S. market in July 2020].
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| My clinic
cannot consistently keep Shingrix in stock due
to high demand. How should we handle challenges ensuring patients receive a second
dose? |
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| Clinicians and
patients should make every effort to ensure
that two doses of Shingrix are administered
within the recommended interval of 2 to 6
months. If more than 6 months have elapsed
since the first dose of Shingrix, administer
the second dose when possible. Do not restart
the vaccine series. If you are out of Shingrix
and a patient needs a second dose, the Vaccine
Finder, sponsored by CDC and other partner
organizations, may be helpful for patients to
locate other providers that have Shingrix in
stock. The Vaccine Finder can be accessed at
www.vaccinefinder.org/find-vaccine or on the
CDC website at
www.cdc.gov/vaccines/vpd/shingles/public/shingrix/index.html. |
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| Additional
information for clinicians about Shingrix is
available on the CDC website at
www.cdc.gov/vaccines/vpd/shingles/hcp/index.html. |
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| Should
Shingrix be given to people who have already
received Zostavax? If so what interval should separate them? |
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| Yes. ACIP
recommends that people who previously received
Zostavax receive 2 doses of Shingrix. The
first dose of Shingrix may be given at least 2
months after Zostavax. |
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| What is the
minimum interval between doses of Shingrix? |
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| The recommended
interval between Shingrix doses is 2 to 6
months. The minimum interval between doses of Shingrix is 4 weeks. If the second dose is
given less than 4 weeks after the first dose
the second dose should be repeated at least 8
weeks after the invalid dose. |
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| What is the
minimum age for administering Shingrix? |
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| The recommended
and minimum age for Shingrix is 50 years.
However, if a dose is inadvertently
administered to an adult 18 through 49 years
of age CDC does not recommend repeating the
dose. The second Shingrix dose should not be
administered until the 50th birthday. This
guidance does not appear in the most recent
zoster ACIP statement but is in the General
Best Practices Guidance (Table 3-1 in the
Timing and Spacing of Immunobiologics section
at
www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html)
and is based on guidance from CDC's zoster
subject matter experts. |
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| If the second
dose of Shingrix is delayed more than 6 months
after the first dose do I need to restart the series? |
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| No. The vaccine
series need not be restarted if more than 6
months have elapsed since the first dose. |
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| Is there an
upper age limit for receipt of zoster vaccine? |
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| No. |
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| If a patient
received dose #1 of varicella vaccine (Varivax,
Merck) at age 60 years, should we administer zoster vaccine as dose #2? |
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| The action taken
depends on why varicella vaccine was given in
the first place. If it was given because the
person tested negative for varicella antibody,
then the next dose should be varicella
vaccine. If the varicella vaccine was given in
error (i.e., without serologic testing), then Shingrix should be given. |
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| Should a
person who received 2 doses of varicella
vaccine be vaccinated with Shingrix when they
turn 50? |
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| In its 2018
zoster vaccine recommendations, the Advisory
Committee on Immunization Practices (ACIP)
states that Shingrix may be used in adults age
50 years or older irrespective of prior
receipt of varicella vaccine or live zoster
vaccine (Zostavax). |
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| Before
administering Shingrix is it necessary to ask
if the person has ever had chickenpox or
shingles? |
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| No. All people
age 50 years or older-whether they have a
history of chickenpox or shingles or
not-should be given Shingrix unless they have
a medical contraindication to vaccination
(described below). It also is not necessary to test for varicella antibody prior to or after
giving the vaccine. |
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| Should people
who haven't had chickenpox be vaccinated with
zoster vaccine? |
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| Serologic studies
indicate that almost everyone born in the
United States before 1980 has had chickenpox
even though many cannot recall having had
chickenpox (www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm.)
As a result, there is no need to ask people
age 50 years and older for their varicella
disease history or to perform a laboratory
test for serologic evidence of prior varicella
disease. A person age 50 years or older who
has no medical contraindications is eligible
for Shingrix regardless of their memory of
having had chickenpox. |
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| Can someone
who has experienced an episode of shingles be
vaccinated with zoster vaccine? |
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| Yes. Adults with
a history of herpes zoster should receive
Shingrix. If a person is experiencing an
episode of zoster, vaccination should be
delayed until the acute phase of the illness
is over and symptoms abate. |
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| If a person
was exposed to shingles by a spouse within the
last few days, is there a recommended waiting period before the exposed person can receive
zoster vaccine? |
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| There is no
waiting period in such a situation. Shingrix
can be given right away or at any time to any
person for whom the vaccine is recommended.
Shingles is not caused by exposure to another
person with shingles. However, exposure to
someone with shingles can possibly cause
chickenpox in a person with no immunity to
varicella zoster virus (VZV) from either
vaccination or prior chickenpox infection.
Zoster is caused by the reactivation of VZV in people who have already had a prior VZV
infection. |
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| A 33-year-old
patient in my practice has already suffered
from three episodes of shingles. He would like
to receive Shingrix. Is this a good idea? |
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| ACIP does not
have a recommendation to administer zoster
vaccine to people younger than 50 years with recurrent zoster episodes. However, clinicians
may choose to administer a vaccine off-label,
if in their clinical judgment, they think the
vaccine is indicated. The patient should be
informed that the use is off-label, and that
the safety and efficacy of the vaccine has not
been tested in people younger than 50. |
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| We have an
18-year-old male who had a history of
chickenpox disease. He now has shingles. We
are unsure what we are to advise for future
treatment. Should we administer zoster
vaccine? |
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| The Advisory
Committee on Immunization Practice (ACIP) does
not recommend zoster vaccination for people younger than age 50 years regardless of their
history of shingles. |
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| Can zoster
vaccine be administered to people in long-term
care facilities? |
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| Yes. Shingrix can
be administered to anyone age 50 years and
older regardless of where they reside, unless
they have a contraindication to vaccination. |
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| Can I give our
long-term care residents zoster vaccine,
injectable influenza, and pneumococcal
vaccines on the same day? |
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| Yes. CDC's
General Best Practice Guidelines for
Immunization advise that non-live vaccines,
such as Shingrix, can be administered
concomitantly, at different anatomic sites,
with any other live or non-live vaccine. They
should be given as separate injections, not
combined in the same syringe. |
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| We know that
documented receipt of Zostavax in the absence
of other criteria is not proof of immunity to varicella. Is this true for Shingrix as well? |
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| Yes. Documented
receipt of Shingrix cannot be used as proof of
immunity to varicella. Additionally, a dose of Shingrix cannot be counted as a dose of
varicella vaccine. |
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| Can I give
Shingrix at the same time as a tuberculin skin
test? |
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| Yes. Shingrix is
not a live virus vaccine and does not
interfere with the tuberculin skin test (TST):
it may be administered any time before or
after a TST. Administration of a live virus
vaccine can interfere with a tuberculin skin
test (TST). If the TST is not administered on
the same day as a live virus vaccine, the TST
should be delayed until 4–6 weeks after the
vaccination. |
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What adverse reactions have been reported with
Shingrix? |
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| In pre-licensure
clinical trials of Shingrix the most common
adverse reactions were pain at the injection
site (78%), myalgia (45%), and fatigue (45%).
Any grade 3 adverse event (reactions related
to vaccination which were severe enough to
prevent normal activities) was reported in 17%
of vaccine recipients compared with 3% of placebo recipients. Grade 3 injection-site
reactions (pain, redness, and swelling) were
reported by 9% of vaccine recipients, compared
with 0.3% of placebo recipients. Grade 3
solicited systemic events (myalgia, fatigue, headache, shivering, fever, and
gastrointestinal symptoms) were reported by
11% of vaccine recipients and 2.4% of placebo
recipients. The occurrence of local grade 3
reactions did not differ by vaccine dose.
However systemic grade 3 reactions were
reported more frequently after dose 2. |
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| Rates of serious
adverse events (an undesirable experience
associated with the vaccine that results in
death, hospitalization, disability or requires
medical or surgical intervention to prevent a
serious outcome) were similar in vaccine and
placebo groups. |
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| What should I
advise my patients about adverse reactions
after Shingrix? |
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| Before
vaccination, providers should counsel Shingrix
recipients about common expected systemic and
local adverse reactions (described above).
Reactions to the first dose do not strongly
predict reactions to the second dose. Shingrix
recipients should be encouraged to complete
the series even if they experienced a grade 3 reaction to the first dose. |
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| Can the
Shingrix vaccine cause shingles? |
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| No. Shingrix
contains only a small part of the herpes
zoster virus and does not contain any live
herpes zoster virus. |
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| What are the
contraindications and precautions to Shingrix? |
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| The only
contraindication is a severe allergic reaction
to a vaccine component or following a prior
dose. The only precaution is the presence of a
moderate or severe acute illness, including
herpes zoster. In that situation, vaccination
should be deferred until the illness improves. |
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| There are no
available data to establish whether Shingrix
is safe in pregnant or lactating women and
there is currently no ACIP recommendation for Shingrix use in this population. Consider
delaying vaccination with Shingrix in such
circumstances. |
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| If an adult
age 50 or older has had zoster with
postherpetic neuralgia or ophthalmic
complications, when can they receive zoster
vaccine? |
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| Once they are no
longer acutely ill, they can be vaccinated
with Shingrix. There is no evidence that
vaccine will have therapeutic effect for a
person with existing zoster or postherpetic
neuralgia. |
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| How long
should we wait before giving zoster vaccine to
a patient who has had a blood transfusion? |
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| There is no
waiting period for administering Shingrix
following transfusion. Shingrix contains no
live virus so may be given at any time after
receipt of a blood product. |
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| Should zoster
vaccine be given to a person who is currently
receiving immunosuppressive treatment? |
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| ACIP recommends
the use of Shingrix in people age 50 or older
taking low-dose immunosuppressive therapy (less than 20 mg/day of prednisone or
equivalent or using inhaled or topical
steroids), or low doses of methotrexate,
azathioprine, or 6-mercaptopurine. |
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| Immunosuppression
is not included as a contraindication in the
manufacturers' package insert. However, immunocompromised people and those on moderate
to high doses of immunosuppressive therapy
were excluded from the clinical efficacy
studies so data were lacking on efficacy and
safety in this group at the time of licensure. ACIP has not yet made a recommendation
regarding the use of Shingrix in these
patients, but is anticipated to do so in the
future. |
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| I have a
patient who is eligible for zoster vaccination
who is going to be receiving chemotherapy
soon. What are the guidelines in such a
situation? |
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| The risk for
zoster and its severe morbidity and mortality
is much greater for immunosuppressed people. A
2-dose series of Shingrix should be
administered as soon as possible while the
person's immune system is intact. |
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| When can a
patient previously on immunosuppressive
chemotherapy receive zoster vaccine? |
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| ACIP has not
specifically addressed the use of Shingrix in
this situation but it is prudent to defer
Shingrix until the patient's immune system has
recovered from the treatment. |
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| Can someone
with hepatitis C receive zoster vaccine? |
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| Hepatitis C
infection is not a contraindication for
Shingrix vaccination. However, if someone with
hepatitis C is receiving a medication that can
cause immunosuppression, they should consult
with their healthcare provider and consider
delaying vaccination with Shingrix until they
have completed treatment. |
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| Can a person
age 60 years or older with a diagnosis of an
autoimmune disease, such as lupus or rheumatoid arthritis, receive zoster vaccine? |
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| Yes. Shingrix can
be administered in this situation. |
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| A 65-year-old
patient is having major back surgery next
week. He is requesting zoster vaccine today.
Can I give him the vaccine? |
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| Yes. Shingrix can
be administered in this situation. |
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| We have a
61-year-old patient who is taking 500 mg of
valacyclovir (Valtrex) daily. Can she receive
zoster vaccine? |
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| Acyclovir,
famciclovir, and valacyclovir are antiviral
drugs that are active against herpesviruses.
These drugs will have no effect on Shingrix,
which does not contain live varicella virus. |
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| If my patient
is taking Tamiflu (oseltamivir), can she
receive zoster vaccine? |
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| Yes. Although
oseltamivir is an antiviral drug, it is only
effective against influenza A and B viruses.
Shingrix does not contain live virus and will
not be affected by oseltamivir. |
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| How are zoster
vaccines administered? |
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| Reconstitute
recombinant zoster vaccine (RZV, Shingrix, GSK)
using only the adjuvant solution provided with
the vaccine antigen. After reconstitution,
administer Shingrix immediately by the
intramuscular route or store the reconstituted
vaccine refrigerated between 2° and 8°C (36°
and 46°F) and use within 6 hours. Discard reconstituted vaccine if not used within 6
hours or if frozen. If Shingrix is
reconstituted with other than the supplied adjuvant solution, it should be repeated. The
dose can be repeated immediately. There is no
interval that must be met between these doses. |
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| A patient was
inadvertently given Shingrix by the
subcutaneous rather than the intramuscular
route. Does the dose need to be repeated? |
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| Shingrix has been
shown to be immunogenic when given by the
subcutaneous route. A dose erroneously given
by this route does not need to be repeated. |
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| When
reconstituted, the volume of Shingrix is more
than 0.5 mL. Should the entire volume of
reconstituted vaccine be administered or just
0.5 mL as indicated in the package insert? |
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| The Shingrix
adjuvant solution may contain up to 0.75 mL of
liquid. The entire volume of the adjuvant
solution should be withdrawn and used to
reconstitute the lyophilized vaccine. After
mixing, withdraw the recommended dose of 0.5 mL. Discard any reconstituted vaccine left in
the vial. |
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| Can
pharmacists in all states administer zoster
vaccine? |
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| According to the
American Pharmacist Association, all states
allow pharmacists to administer zoster
vaccine. Not all pharmacists provide
vaccination services, and of those who do, not
all administer zoster vaccine. It is best to call the pharmacy ahead of time to find out if
they have Shingrix to administer to your
patients. The vaccine must be administered in
the pharmacy. Do NOT instruct the patient to
transport the vaccine from the pharmacy back
to your office. This could damage the potency
of the vaccine. |
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| A 60-year-old
patient was inadvertently given varicella
vaccine instead of Shingrix. Should the
patient still be given Shingrix? If so, how
long an interval should occur between the 2
doses? |
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| CDC recommends
that if a provider mistakenly administers
varicella vaccine to a person for whom zoster
vaccine is indicated, no specific safety
concerns exist, but the dose should not be
considered valid. Shingrix should be administered at least 8 weeks after receipt of
the varicella vaccine. However, if Shingrix is
administered less than 8 weeks after the
varicella vaccine, it does not need to be
repeated. A second dose of Shingrix should be
given 2–6 months after the first dose of
Shingrix. Avoid such errors by checking the
vial label 3 times to make sure you're administering the product you intended. |
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| If Shingrix is
erroneously given to a child for prevention of
varicella, the dose is invalid, but is there a waiting period before a valid dose of
varicella vaccine can be given? Is it OK to
give a dose of varicella vaccine as soon as
the error is discovered? |
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| There is no
waiting period. The varicella vaccine dose can
be given at any time after the Shingrix dose. |
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| We
inadvertently gave a 47-year-old healthcare
worker Shingrix rather than varicella vaccine
for work. Does this dose count? |
|
| No. The Shingrix
vaccine does not count as a vaccination
against primary varicella infection
(chickenpox). The first varicella vaccine dose
can be given at any time after the Shingrix
dose. The second dose of varicella vaccine should be given 4 to 8 weeks after the first
dose. You should always check the label 3
times to ensure you are administering the
product intended. |
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| While giving a
dose of Shingrix the syringe came loose from
the needle and part of the dose was lost. Will the patient be protected with this partial
dose or does it need to be repeated? |
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| A dose less than
the full 0.5 mL dose is not valid and should
be repeated. If the patient is still in the
office the dose can be repeated immediately.
If the repeat dose cannot be given on the same
day CDC recommends that it should be given 4
weeks after the invalid dose. |
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| My medical
assistant inadvertently administered a 0.5 mL
dose of the Shingrix diluent only. The dose
did not contain any antigen. When can we
administer a properly reconstituted dose? |
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| The CDC zoster
subject matter experts recommend that in this
situation you should wait 4 weeks before
giving a repeat dose. |
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| Several doses
(antigen and diluent) of Shingrix were
mistakenly stored in our office freezer. One
of these doses was administered to a patient.
Is this dose valid and if not, when can it be
repeated? |
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| Any Shingrix,
either antigen or diluent, that is exposed to
freezing temperature should not be used. If a
dose exposed to freezing temperature is given
to a patient the dose should be considered
invalid and should be repeated 4 weeks after
the invalid dose. |
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| How should
Shingrix be stored? |
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| Both lyophilized
Shingrix and the adjuvant solution diluent
must be stored at refrigerator temperature,
between 2° and 8°C (between 36° and 46°F).
Protect the vials from light. Do not freeze.
Vaccine or adjuvant solution that has been
frozen must be discarded. If vaccine that was
frozen was administered, the dose does not
count and should be repeated. The repeat dose
should be administered 4 weeks after the
frozen dose.
After reconstitution, administer Shingrix
immediately or store refrigerated between 2°
and 8°C (between 36° and 46°F) and use within
6 hours. Discard reconstituted vaccine if not
used within 6 hours. |
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| How should
Shingrix be transported to an off-site clinic
location? |
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| Shingrix is
stored at refrigerator temperature. Transport
of refrigerated vaccines is described in
detail in the CDC Storage and Handling
Toolkit, available at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit-2020.pdf,
pages 22–24. Providers should also review the
vaccine package inserts for the specific
vaccines being transported. |
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ACIP Recommendations
Vaccine Information Statements 
